SedationPhase 4NCT01255904

A Trial Of Oral Chloral Hydrate Versus Intranasal Dexmedetomidine For Sedated Abr Exams

A Phase 4 study testing Chloral Hydrate and Dexmedetomidine in people with Sedation, run by Baylor College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to compare the efficacy of oral chloral hydrate to intranasal dexmedetomidine for the successful completion of a sedated ABR exam (hearing exam). Read more about this study

Who is it for?: Ages 6 months to 8 years
Conditions the study is for: Sedation
What is being tested?: Chloral Hydrate and Dexmedetomidine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: 1 siteUnited States
Study dates: Aug 2011to Nov 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months to 8 years
All sexes
No healthy volunteers
Child

Who may be able to join

Patient scheduled for ABR exam with sedation to be administered according to protocol by nurse in keeping with standard practice at the TCH Audiology clinic.

Who cannot join

Patients younger than 6 months or older than 8 years
Previously failed sedation
Weight greater than 25 kg
Weight less than 5 kg
BMI above 30
Diagnosis of ADHD

Show all 9Show fewer

Any patient deemed inappropriate for nurse administered sedation
Patients with any cardiac disease
Obstructive sleep apnea

Trial locations and contacts

1 site in 1 country.

United States1 site

Texas Childrens Hospital
Houston, Texas, 77030

Other trials in United States

About this study

Official title: A RANDOMIZED CONTROLLED TRIAL OF ORAL CHLORAL HYDRATE VERSUS INTRANASAL DEXMEDETOMIDINE FOR SEDATED ABR EXAMS.

The purpose of this study is to compare the efficacy of oral chloral hydrate to intranasal dexmedetomidine for the successful completion of a sedated ABR exam (hearing exam).

Conditions: Sedation
Being tested: Chloral Hydrate, Dexmedetomidine, Oral placebo, Intranasal placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Chloral HydrateDrug
Oral chloral hydrate 50 mg/kg
DexmedetomidineDrug
Intranasal dexmedetomidine 3 mcg/kg
Oral placeboOther
Oral saline administered
Intranasal placeboOther
Intranasal saline administered

Study groups in NCT01255904
Study group	Role	What they receive
Arm 1	Experimental	Oral Chloral and intranasal placebo Receives: Drug: Chloral Hydrate; Other: Intranasal placebo
Arm 2	Experimental	oral placebo and intranasal dexmedetomidine Receives: Drug: Dexmedetomidine; Other: Oral placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Complete Study
Time from medication administration to study completion.
Measured: 60-180 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Nov 2014

First posted8 Dec 2010 (estimated)
Study startAug 2011
Primary completionNov 2014
Study completionNov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SedationStudies of the same condition, open and under way.
More trials run by Baylor College of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01255904
Sponsor's protocol ID: H-27453
Status last verified: Apr 2016
First submitted: 18 Nov 2010
Last updated: 16 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Fong CY, Lim WK, Li L, Lai NM. Chloral hydrate as a sedating agent for neurodiagnostic procedures in children. Cochrane Database Syst Rev. 2021 Aug 16;8(8):CD011786. doi: 10.1002/14651858.CD011786.pub3.
PubMed 34397100

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sedation trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A RANDOMIZED CONTROLLED TRIAL OF ORAL CHLORAL HYDRATE VERSUS INTRANASAL DEXMEDETOMIDINE FOR SEDATED ABR EXAMS.
ClinicalTrials.gov ID: NCT01255904
Acronym / sponsor ID: H-27453
Conditions: Sedation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Baylor College of MedicineUniversity, hospital or other
Study start: Aug 2011
Primary completion: Nov 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 8 Dec 2010 (estimated)
Results: Posted 22 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to compare the efficacy of oral chloral hydrate to intranasal dexmedetomidine for the successful completion of a sedated ABR exam (hearing exam).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Arm 1	Experimental	Drug: Chloral Hydrate, Other: Intranasal placeboOral Chloral and intranasal placebo
Arm 2	Experimental	Drug: Dexmedetomidine, Other: Oral placebooral placebo and intranasal dexmedetomidine

Who may qualify

Ages: 6 months to 8 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

Patient scheduled for ABR exam with sedation to be administered according to protocol by nurse in keeping with standard practice at the TCH Audiology clinic.

Key exclusion criteria (9 listed)

Patients younger than 6 months or older than 8 years
Previously failed sedation
Weight greater than 25 kg
Weight less than 5 kg
BMI above 30

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Chloral HydrateOral chloral hydrate 50 mg/kg	Drug	Arm 1
DexmedetomidineIntranasal dexmedetomidine 3 mcg/kg	Drug	Arm 2
Oral placeboOral saline administered	Other	Arm 2
Intranasal placeboIntranasal saline administered	Other	Arm 1

Primary outcome

Time to Complete Study
Time frame: 60-180 minutes
Time from medication administration to study completion.

Results and safety

Results posted to the registry on 22 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oral Placebo and Intransal Dexmedetomidine	45	44
Oral Chloral Hydrate and Intranasal Placebo	45	41

Primary outcome: Time to Complete Study

Time frame: 60-180 minutes. Median (95% Confidence Interval). Unit: Minutes

Measure	Oral Placebo and Intransal Dexmedetomidine n = 44	Oral Chloral Hydrate and Intranasal Placebo n = 41
Value	85.5 (80 to 110)	110 (85 to 119)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oral Placebo and Intransal Dexmedetomidine	0 of 44 (0%)	2 of 44 (4.5%)	Not reported
Oral Chloral Hydrate and Intranasal Placebo	0 of 41 (0%)	0 of 41 (0%)	Not reported

Limitations and caveats (from the sponsor): This study was not designed to detect small differences in rare adverse and the overall safety of either medication cannot be assessed based on these results alone.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34397100Fong CY, Lim WK, Li L, Lai NM. Chloral hydrate as a sedating agent for neurodiagnostic procedures in children. Cochrane Database Syst Rev. 2021 Aug 16;8(8):CD011786. doi: 10.1002/14651858.CD011786.pub3.

Related trials for Sedation

Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 3
A Study of Changes to Prostate Procedures
Prostate Cancer
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruitingObservational study
Media Use, Anxiety, Sedation, and Recovery in Children Having Upper GI Endoscopy
Anesthesia, Anxiety

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Chloral Hydrate and Dexmedetomidine in people with Sedation, run by Baylor College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Complete Study (time frame: 60-180 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01255904, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016.